BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS 2008K

    MDR report key: 3608423 · Received January 13, 2014

    Report

    Report Number
    2937457-2014-00033
    Event Type
    Death
    Date Received
    January 13, 2014
    Date of Event
    September 6, 2011
    Report Date
    January 3, 2014
    Manufacturer
    FRESENIUS USA, INC.
    Product Code
    KDI
    PMA / PMN Number
    994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS: ASSOCIATED MDRS #1225714-2014-00105, 1225714-2014-001006 AND 2937457-2014-00033.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON OR ABOUT (B)(6) 2011, AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23536 FRESENIUS 2008K KDI FRESENIUS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death